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Post by JHam on Sept 9, 2014 12:43:20 GMT
And just like that, here is one of the PR's I was expecting: ir.oncosec.com/company-news/detail/1514OncoSec Medical to Present Data at ESMO 2014 Congress Download PDF SAN DIEGO-- OncoSec Medical Inc. (OTCQB: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will present data from ongoing clinical and pre-clinical studies at the European Society for Medical Oncology (ESMO) 2014 Congress, to be held September 26-30 in Madrid, Spain. OncoSec is proud to be presenting an abstract titled, “Immune correlates of intratumoral IL-12 electroporation”, as part of a poster presentation taking place 12:45 PM - 1:45 PM CEST on Sunday, September 28th. “The data we are presenting support the ability of intratumoral electroporation of IL-12 to generate not just a local anti-tumor response, but evidence of response in distant lesions,” said Robert H. Pierce, M.D., Chief Medical Officer at OncoSec. “Additionally, pharmacodynamic data from tumor biopsy samples obtained from patients participating in our ongoing Phase 2 melanoma study are consistent with preclinical data in the B16 melanoma mouse model, where we demonstrated that IL-12 is turning on an interferon-gamma-driven signaling cascade, culminating in the accumulation of tumor infiltrating lymphocytes, or TILs, which have been shown to correlate with response to anti-PD-1 therapies. Based on this biology, we will be testing the hypothesis that intratumoral electroporation with IL-12 will help convert PD-1 non-responders into responders.” OncoSec’s President and CEO, Punit Dhillon, said, “It is our distinct honor to present our latest findings before the prestigious ESMO 2014 Congress. Events like ESMO 2014 enable important iterative thinking in the evolving field of cancer biology, clinical oncology and the related development of new therapies, all of which continue to provide new options for patients in the ongoing effort to provide new treatments for these difficult cancers. We are confident that OncoSec is contributing to this collective body of knowledge through our unique technology and development path forward. Based on the data we are presenting here at ESMO 2014, and the FDA’s recent accelerated approval of the first PD-1 inhibitor pembrolizumab (Keytruda®, Merck), we are excited to now have the opportunity to investigate clinically the potential benefit of our proprietary intratumoral electroporation therapy with IL-12 to treat patients who do not respond to anti-PD-1 therapy.” Abstract information is as follows: Abstract #1620P: Immune correlates of intratumoral IL-12 electroporation. R. Pierce. Sunday, September 28, 12:45 PM – 1:45 PM CEST. Madrid, Spain About ESMO 2014 ESMO is Europe’s leading medical oncology society, and is dedicated to informing, educating, and supporting each individual practitioner and researcher in the rapidly evolving medical oncology landscape. The theme for ESMO 2014 is ‘Precision Medicine in Cancer Care’. This year’s congress will feature presentations of some of the latest research and trials including targeted therapies and immunotherapeutic approaches, joint symposia with representatives of all cancer specialties, and robust debates on the clinical challenges of supplying genuinely personalized cancer treatment. The event is designed to provide attendees and participants with plentiful opportunities to make new contacts, discuss new findings, learn from experts, and review presentations – both online and at the Congress itself. For more information, please visit: www.esmo.org/Conferences/ESMO-2014-Congress |
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Post by JHam on Sept 9, 2014 12:52:28 GMT
There are so many nuggets of information in this PR.
1. They will be presenting the final data for the Phase 2 Melanoma trial (although we ready know that data is good)
2. They will be presenting new data on the mouse trial showing that they can convert anti-PD1 responders into non-responders. They said they could do it, but have been sitting on the actual data until now
3. More references to Merck and the FDA accelerated approval of Keytruda and how it pertains to ONCS and their Phase 2b study
Based on the data we are presenting here at ESMO 2014, and the FDA’s recent accelerated approval of the first PD-1 inhibitor pembrolizumab (Keytruda®, Merck), we are excited to now have the opportunity to investigate clinically the potential benefit of our proprietary intratumoral electroporation therapy with IL-12 to treat patients who do not respond to anti-PD-1 therapy.”
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Post by JHam on Sept 9, 2014 14:12:56 GMT
Aaaaand it's getting destroyed on this news. I think people were hoping that "the big" announcement would happen today before the conference blitz started. It makes no difference to me since this is a long term hold.
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Post by JHam on Sept 16, 2014 20:11:30 GMT
Looks like we could see the ESMO abstracts posted tomorrow at 6am est:
Abstracts accepted for presentation at ESMO 2014 as Poster Discussion and Poster will be published online on the ESMO website at 12:00 local Swiss time on Wednesday, 17 September 2014.
Very curious to see what we can learn from ONCS' abstract. Hopefully an outline of the new data.
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Post by JHam on Sept 17, 2014 16:36:02 GMT
Here is the Abstract. It is really good data. Note the 20/20 regression number in treated tumors:
1620P - Immune correlates of intratumoral IL-12 electroporation
R. Pierce (San Diego, United States of America)
K. Takamura (San Diego, United States of America)
S. Shirley (Norfolk, United States of America)
S. Chan (San Francisco, United States of America)
J. Lewis (San Francisco, United States of America)
J. Campbell (San Diego, United States of America)
L. Fong (San Francisco, United States of America)
T. Diep (San Diego, United States of America)
R. Heller (Norfolk, United States of America)
A. Daud (San Francisco, United States of America)
Aim
Intratumoral (IT) electroporation (EP) of plasmid IL-12 promotes systemic anti-tumor immunity and is being evaluated in Phase 2 trials. In patients (pts) with advanced melanoma (MEL) treated with IL-12 EP, regression of non-injected lesions was seen in 4/19 pts in the Phase I study and 13/21 pts in the ongoing Phase 2 study. This study explores systemic efficacy and immune correlates in clinical samples and in a bilateral MEL model, utilizing the poorly immunogenic B16 cell line, to test the hypothesis that intratumoral IL-12 EP can enhance tumor immunogenicity.
Methods
Pre- and post-treatment biopsies and blood were collected from MEL trial pts. A B16 2-tumor MEL model was developed in mice. Tumors treated with IL-12 EP were compared to untreated tumors in the same animal. mRNA was evaluated by NanoString and leukocyte populations by IHC and flow cytometry.
Results
Analyses of clinical samples indicated a doubling of NK cells in the treated tumor as well as increased frequency in activated NK cells in circulation. In the B16 model, complete regression was seen in 20/20 treated tumors at post-treatment day 7 and 4/10 untreated tumors at day 18 or 22. Regression in untreated tumors was accompanied by a TIL infiltrate and transcriptional profile consistent with increased NK, CD8, CD4 and Tregs. In addition, the infiltrate was associated with increased mRNA for PD-1, PD-L1, IFNg and IFNg-inducible genes involved in antigen presentation and processing.
Conclusions
IL-12 EP results in regression of untreated lesions in pts and mice. Analysis of IL-12 EP-treated tumors showed a pattern consistent with NK cell infiltration, IFNg expression and upregulation of IFNg-driven genes, including ones involved in antigen processing and presentation. In mice, where untreated tumors were systematically analyzed, a TIL infiltrate and transcriptional IFNg-program was identified consistent with enhanced B16 immunogenicity. This model provides insights into the immune reactions in both the electroporated tumor and in untreated lesions. Although preliminary, data from the B16 model and IL-12-treated pts support the hypothesis that augmentation of immunogenicity is a component of IL-12’s systemic anti-tumor effects. Less
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Post by JHam on Sept 18, 2014 20:48:34 GMT
I finally had a sec to sit down and go over review this data. I realize I rarely have anything negative to say about this stock/company and that that can be dangerous, but in my opinion it is hard to come to any conclusion other than "spectacular" when looking at this abstract. Here is my quick breakdown:
They are presenting data from a couple different studies. The main three points are as follows:
1. Intratumoral electroporation of IL-12 generates a local as well as distant response. We knew this, but will finally get to see data on it (nothing to do with anti-PD-1).
2. Data from the Phase II melanoma trial support the findings from the B16 preclinical mouse that IL-12 increases TIL (again we knew this and again nothing to do with anti-PD-1).
3. 20/20 of the B16 mice showed complete regression in pre-clinical trials. This is the pre-clinical data combining IL-12 with an anti-PD-1 checkpoint inhibitor that many of us have been waiting for. They said a while back that pre-clinical studies showed 100% response/regression, but they had yet to show the data.
So basically they completely cured cancer in 20 out of 20 mice when they combined IL-12 with anti-PD-1:
"Results
Analyses of clinical samples indicated a doubling of NK cells in the treated tumor as well as increased frequency in activated NK cells in circulation. In the B16 model, complete regression was seen in 20/20 treated tumors at post-treatment day 7 and 4/10 untreated tumors at day 18 or 22. Regression in untreated tumors was accompanied by a TIL infiltrate and transcriptional profile consistent with increased NK, CD8, CD4 and Tregs. In addition, the infiltrate was associated with increased mRNA for PD-1, PD-L1, IFNg and IFNg-inducible genes involved in antigen presentation and processing."
And it is due to the combination with intratumoral electroporation of IL-12 (i.e. Immunopulse). We know from point 2. above that IL-12 injected into the B16 mouse models is what caused their TIL to increase (become responders), and that because of that, they saw full regression.
Pretty exciting stuff. I'm very anxious to hear the presentation in Spain and see the data on the 28th.
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Post by JHam on Sept 23, 2014 12:36:02 GMT
I wouldn't be surprised if we see another small run up as we head towards the end of this week.
With the presentation of new, and what looks to be, very promising data on Sunday, some investors may want to get in before the weekend. The abstract alone was enough for me in my opinion for the market to respond to, but it didn't so much, so who knows.
I do think that once they present this data the data for Phase II on Melanoma and then the MCC trial is not to far off. Which then sets the stage for the announcement of Phase IIb. In my opinion until those two data sets are released we won't hear the biggest news, which is the Phase IIb trial and their partner.
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Post by happyjawa on Sept 23, 2014 21:04:49 GMT
You read my mind. I've been waiting for funds to settle since last week and I have another order in for tomorrow morning.
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Post by JHam on Sept 24, 2014 10:22:52 GMT
You read my mind. I've been waiting for funds to settle since last week and I have another order in for tomorrow morning. So you feel better about this one now than you did a few weeks ago? |
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Post by happyjawa on Sept 25, 2014 2:48:30 GMT
You read my mind. I've been waiting for funds to settle since last week and I have another order in for tomorrow morning. So you feel better about this one now than you did a few weeks ago? I feel great about the stock long term, I just hate short term cheer leading. "They are presenting data from a couple different studies. The main three points are as follows:
1. Intratumoral electroporation of IL-12 generates a local as well as distant response. We knew this, but will finally get to see data on it (nothing to do with anti-PD-1).
2. Data from the Phase II melanoma trial support the findings from the B16 preclinical mouse that IL-12 increases TIL (again we knew this and again nothing to do with anti-PD-1)."
3. 20/20 of the B16 mice showed complete regression in pre-clinical trials. This is the pre-clinical data combining IL-12 with an anti-PD-1 checkpoint inhibitor that many of us have been waiting for. They said a while back that pre-clinical studies showed 100% response/regression, but they had yet to show the data."Stuff like that makes me think, "Yeah, this is going to be good," but I just hate getting on these boards and seeing people freak out over small price movements. It's a penny stock. Let the price stay between .40-.60 until they take it to market and I'll keep gobbling up shares provided they keep posting positive news. Eventually news will come out that pushes this stock out of the pennies and onto a bigger exchange. Until then, I like to poo-poo on talk of price movements. I think you already mentioned ONCS in relations to ACTCD and being a cult stock. Well, between the cultists and the traders, I reckon there's going be at least some short term movement coming up and I'd like to claim some of my future profits early while I wait for that science to catch up with our expectations. There should be a steady stream of conferences this year that should keep ONCS releasing PR and keeping people excited. |
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Post by JHam on Sept 25, 2014 2:55:40 GMT
So you feel better about this one now than you did a few weeks ago? I feel great about the stock long term, I just hate short term cheer leading. "They are presenting data from a couple different studies. The main three points are as follows:
1. Intratumoral electroporation of IL-12 generates a local as well as distant response. We knew this, but will finally get to see data on it (nothing to do with anti-PD-1).
2. Data from the Phase II melanoma trial support the findings from the B16 preclinical mouse that IL-12 increases TIL (again we knew this and again nothing to do with anti-PD-1)."
3. 20/20 of the B16 mice showed complete regression in pre-clinical trials. This is the pre-clinical data combining IL-12 with an anti-PD-1 checkpoint inhibitor that many of us have been waiting for. They said a while back that pre-clinical studies showed 100% response/regression, but they had yet to show the data."Stuff like that makes me think, "Yeah, this is going to be good," but I just hate getting on these boards and seeing people freak out over small price movements. It's a penny stock. Let the price stay between .40-.60 until they take it to market and I'll keep gobbling up shares provided they keep posting positive news. Eventually news will come out that pushes this stock out of the pennies and onto a bigger exchange. Until then, I like to poo-poo on talk of price movements. I think you already mentioned ONCS in relations to ACTCD and being a cult stock. Well, between the cultists and the traders, I reckon there's going be at least some short term movement coming up and I'd like to claim some of my future profits early while I wait for that science to catch up with our expectations. There should be a steady stream of conferences this year that should keep ONCS releasing PR and keeping people excited. Nice, and I agree. I am not interested in cheerleading short term gains in a holding if it is a long term value play for me. (I don't recall ever doing that with ONCS either). I do like seeing the share price rise in coordination with a milestone being met though. I also think that it will be a pretty busy end of the year on the news front. |
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Post by happyjawa on Sept 25, 2014 3:35:38 GMT
I feel great about the stock long term, I just hate short term cheer leading. "They are presenting data from a couple different studies. The main three points are as follows:
1. Intratumoral electroporation of IL-12 generates a local as well as distant response. We knew this, but will finally get to see data on it (nothing to do with anti-PD-1).
2. Data from the Phase II melanoma trial support the findings from the B16 preclinical mouse that IL-12 increases TIL (again we knew this and again nothing to do with anti-PD-1)."
3. 20/20 of the B16 mice showed complete regression in pre-clinical trials. This is the pre-clinical data combining IL-12 with an anti-PD-1 checkpoint inhibitor that many of us have been waiting for. They said a while back that pre-clinical studies showed 100% response/regression, but they had yet to show the data."Stuff like that makes me think, "Yeah, this is going to be good," but I just hate getting on these boards and seeing people freak out over small price movements. It's a penny stock. Let the price stay between .40-.60 until they take it to market and I'll keep gobbling up shares provided they keep posting positive news. Eventually news will come out that pushes this stock out of the pennies and onto a bigger exchange. Until then, I like to poo-poo on talk of price movements. I think you already mentioned ONCS in relations to ACTCD and being a cult stock. Well, between the cultists and the traders, I reckon there's going be at least some short term movement coming up and I'd like to claim some of my future profits early while I wait for that science to catch up with our expectations. There should be a steady stream of conferences this year that should keep ONCS releasing PR and keeping people excited. Nice, and I agree. I am not interested in cheerleading short term gains in a holding if it is a long term value play for me. (I don't recall ever doing that with ONCS either). I do like seeing the share price rise in coordination with a milestone being met though. I also think that it will be a pretty busy end of the year on the news front. I don't mean to imply that anybody has been getting preachy with the stock price, so I hope I don't come off as some sort of negative angry man whenever I post. I don't have access to great internet currently, so I appreciate your posts and summaries of everything that's going on because I can't spend a large amount of time constantly working on notes and (re)watching conferences presentations. I'm looking forward to a great 2014/2015 with ONCS. |
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Post by JHam on Sept 25, 2014 3:59:48 GMT
Nice, and I agree. I am not interested in cheerleading short term gains in a holding if it is a long term value play for me. (I don't recall ever doing that with ONCS either). I do like seeing the share price rise in coordination with a milestone being met though. I also think that it will be a pretty busy end of the year on the news front. I don't mean to imply that anybody has been getting preachy with the stock price, so I hope I don't come off as some sort of negative angry man whenever I post. I don't have access to great internet currently, so I appreciate your posts and summaries of everything that's going on because I can't spend a large amount of time constantly working on notes and (re)watching conferences presentations. I'm looking forward to a great 2014/2015 with ONCS. I didn't think that at all, I just wanted to clarify that I wasn't coming across that way, lol. Yeah definitely excited about what's to come the rest of this year. |
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Post by JHam on Oct 1, 2014 12:49:12 GMT
So I was wrong about the mouse data that was presented in Spain the other day. Actually I wasn't at first. I challenged the "all-knowing" furbush at Yahoo that this was actually that data, because since it didn't mention anywhere in the abstract that it was a combined study, one could only assume that it was. Which is what furbush did. Although it was a logical guess, it was incorrect, as it was only an IL-12 trial. After he made some points and insulted a few people I assumed he was probably correct, since he usually is. Lesson learned to trust your own DD.
Anyway, it is not really a big deal, as we know there is a mouse trial out there that had a 100% response and cure rate in mice. This just wasn't it. It was a different mouse study that still looks like it had a 100% cure rate with only IL-12. But until I find out more about this study, I'd just be throwing out complete wild guesses.
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